EVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
FDA device recall Z-2244-2024 · posted 2024-07-01 · Open, Classified
Recall details
- Recalling firm
- MicroPort Orthopedics Inc.
- Reason for recall
- One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
- Action taken
- The recalling firm issued the FSN, dated 05/02/2024, via email. The required actions were to: Immediately check inventory and quarantine all subject product(s); COMPLETE AND RETURN the attached FSCA Acknowledgement; Inform MicroPort Orthopedics of any adverse event immediately; Return any affected product to: MicroPort Orthopedics Inc. 1481 Gulf Stream, Arlington, TN 38002. The consignee is to mark all return shipping boxes with RECALL on several sides for better identification and processing.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HRY
- Quantity affected
- 40 units
- Distribution
- International distribution in the country of China. There is no field inventory in the United States for either lot.
- Date initiated
- 2024-05-03
- Date posted
- 2024-07-01
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVOLUTION MP TOTAL KNEE SYSTEM (K102380) | Wrightmedicaltechnologyinc | 2011-01-07 |
| EVOLUTION MP TOTAL KNEE SYSTEM (K093552) | Wrightmedicaltechnologyinc | 2010-03-04 |